Rhabdomyolysis News and Research

RSS

Rhabdomyolysis (often shortened to simply "rhabdo") is the rapid breakdown (''lysis'') of skeletal muscle (''rhabdomyo'') due to injury to muscle tissue.

FDA accepts Merck's NDA for NOXAFIL tablets

Merck, known as MSD outside the United States and Canada, today announced that its New Drug Application for an investigational, tablet formulation of the company's antifungal agent, NOXAFIL (posaconazole), has been accepted for review by the U.S. Food and Drug Administration.

11 Apr 2013

Otsuka receives FDA approval for ABILIFY MAINTENA to treat schizophrenia

Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) announced the U.S. Food and Drug Administration (FDA) has approved ABILIFY MAINTENA (aripiprazole) for extended- release injectable suspension, an intramuscular (IM) depot formulation indicated for the treatment of schizophrenia.

1 Mar 2013

Physicians beware of fruity drug interactions

An understanding of the potential for pharmacokinetic interaction between orally administered drugs and grapefruit is necessary in view of an increase in marketed medications that fit the risk criteria, suggest Canadian researchers.

30 Nov 2012

FDA accepts Sunovion’s two LATUDA sNDAs for review

Sunovion Pharmaceuticals Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted for review two supplemental New Drug Applications (sNDAs) for the use of LATUDA as 1) monotherapy and 2) adjunctive therapy to lithium or valproate, both to treat adult patients with depressive episodes associated with bipolar I disorder (bipolar depression).

31 Oct 2012

Important data from Pfizer’s lung cancer and RCC portfolios to be presented at ESMO Congress

Pfizer Oncology today announced that important data from its lung cancer and renal cell carcinoma (RCC) portfolios will be presented at the upcoming European Society for Medical Oncology (ESMO) Congress in Vienna, Austria, September 28 - October 2, 2012.

18 Sep 2012

EC grants marketing authorization for Pfizer’s INLYTA to treat renal cell carcinoma

Pfizer Inc. announced today that the European Commission (EC) has granted marketing authorization for INLYTA (axitinib) for the treatment of adult patients with advanced renal cell carcinoma (RCC), a type of kidney cancer, after failure of prior treatment with sunitinib or a cytokine.

4 Sep 2012

Statin's potency may cause muscle problems in patients with cardiovascular disease

A study from the University of California, San Diego School of Medicine, published August 22 online by PLoS ONE, reports that muscle problems reported by patients taking statins were related to the strength or potency of the given cholesterol-lowering drugs.

23 Aug 2012

Combination therapy does not change safety and efficacy relationship of TORISEL for advanced RCC

Pfizer Inc. announced that the Phase 3 INTORACT trial (B1771006), evaluating the combination of bevacizumab plus TORISEL (temsirolimus) compared with bevacizumab plus interferon-alfa-2a (IFN-α-2a) in the first-line treatment of patients with advanced renal cell carcinoma (RCC) across risk groups, did not meet its primary endpoint of superiority in extending progression free survival (PFS) in the study population.

12 Aug 2012

Lilly, Kowa announce results from PREVAIL U.S. study

Kowa Pharmaceuticals America, Inc. and Eli Lilly and Company today announced results of the PREVAIL U.S. study (Pitavastatin compaREd with praVAstatin In Lowering LDL-C in the U.S.) which evaluated the efficacy of LIVALO (pitavastatin) 4 mg compared with pravastatin 40 mg in reducing low-density lipoprotein cholesterol (LDL-C), the primary endpoint, as well as effects on other lipid parameters and lipoprotein particles in adult patients with primary hyperlipidemia or mixed dyslipidemia.

2 Jun 2012

Pfizer fails to meet primary endpoint in TORISEL Phase 3 study for advanced RCC

Pfizer Inc announced that the Phase 3 INTORSECT (B1771003) study, evaluating TORISEL(temsirolimus) in patients with advanced renal cell carcinoma (RCC) whose disease had progressed on or after SUTENT (sunitinib malate) therapy, did not meet the primary endpoint of prolonging progression free survival (PFS) when compared to sorafenib.

16 May 2012

Sunovion announces results from LATUDA open-label study for schizophrenia

Sunovion Pharmaceuticals Inc. today announced results from an open-label study that switched clinically stable, but symptomatic adult outpatients with schizophrenia from other antipsychotic agents to LATUDA.

10 May 2012

Positive results from Dainippon Sumitomo Pharma's LATUDA trials for bipolar I depression

Dainippon Sumitomo Pharma Co., Ltd. announced today results from two Phase 3 clinical trials designed to evaluate the efficacy and safety of LATUDA as adjunctive therapy and monotherapy, respectively, in patients with bipolar I depression (PREVAIL 1 and PREVAIL 2; PRogram to EValuate the Antidepressant Impact of Lurasidone).

7 May 2012

Galeterone safe, effective for patients with CRPC

Patients with castration-resistant prostate cancer had limited side effects and in many cases a drop in prostate-specific antigen expression with galeterone (TOK-001), a small-molecule oral drug, according to phase I data presented at the AACR Annual Meeting 2012, held here March 31 - April 4.

2 Apr 2012

FDA denies AstraZeneca Citizen Petitions on SEROQUEL labeling

AstraZeneca today announced that on March 7, 2012, the Food and Drug Administration denied Citizen Petitions requesting that the FDA withhold finally approving any generic quetiapine product with labeling that omits certain hyperglycemia warning language that the FDA required AstraZeneca to include in the labeling for SEROQUEL (quetiapine fumarate) tablets and SEROQUEL XR (quetiapine fumarate) extended-release tablets.

12 Mar 2012

ACTF, Merck announce new HIV initiatives

Today, Merck, known as MSD outside the United States and Canada, and the ADAP Crisis Task Force (ACTF) announced a number of new initiatives to help struggling state AIDS Drug Assistance Programs (ADAPs) continue to provide access to medicines to people living with HIV.

22 Dec 2011

FDA EMDAC votes to recommend approval of Merck's VYTORIN for pre-dialysis CKD

Merck, known as MSD outside the United States and Canada, announced today that the Endocrinologic and Metabolic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) unanimously voted to recommend approval of Merck's VYTORIN (ezetimibe/simvastatin) for use in patients with pre-dialysis chronic kidney disease.

3 Nov 2011

Merck announces results from ISENTRESS Phase III combination study on HIV-1

Merck, known as MSD outside the United States and Canada, today announced results of new exploratory pre-specified analyses from the ongoing STARTMRK Phase III study of its integrase inhibitor ISENTRESS (raltegravir) Tablets in combination therapy compared to efavirenz in combination therapy in previously untreated adult HIV-1-infected patients.

14 Oct 2011

Merck receives FDA approval for JUVISYNC to treat type 2 diabetes

Merck, known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has approved JUVISYNC(sitagliptin and simvastatin), a new treatment for type 2 diabetes that combines the glucose-lowering medication sitagliptin, the active component of JANUVIA (sitagliptin), with the cholesterol-lowering medication ZOCOR.

10 Oct 2011

ISENTRESS demonstrates comparable efficacy to efavirenz in treatment-naïve adult HIV-1 patients

Merck, known as MSD outside the United States and Canada, today announced final results from a Phase II clinical study, extending out to 240 weeks, of its integrase inhibitor ISENTRESS® (raltegravir) Tablets in combination therapy in previously untreated (treatment-naïve) adult HIV-1-infected patients.

18 Jul 2011

Zocor, Crestor drugs may cause serious muscle and kidney problems

Crestor and Zocor are widely-used prescription strength drugs designed to lower "bad cholesterol". Both drugs are classified as "statins", medicine which lowers blood cholesterol levels by inhibiting HMG-CoA reductase.

16 Jul 2011